Category Archives: Topics

Wegovy Label Update; Jardiance Receives EMPA-KIDNEY Approval in EU; Glucotrack Announces Positive Implantable CGM Data; Thane Wettig Succeeds Enrique Conterno as Fibrogen CEO

Four cardiometabolic-related news items have been observed: The Wegovy US label has been updated to include 1.7mg as a second maintenance dose in addition to the 2.4mg dose (view label); BI/Lilly announced the European Commission (EC) approved Jardiance for the treatment of adults with CKD (view press release); Glucotrack announced positive results from the feasibility study for its implantable CGM (view press release); and Fibrogen announced the resignation of Enrique Conterno, with Thane Wettig taking over as interim CEO (view press release). Below, FENIX provides highlights and insights on the respective news items, including insight into Novo’s potential rationale for adding another Wegovy maintenance dose.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Biocon Receives Even More Form 483 Observations; Roche and Alnylam Partner for Hypertension RNAi; Dario Issues Preliminary Q2 ’23 Results and Business Update

Three cardiometabolic-related news items have been observed: Biocon announced FDA conducted two cGMP inspections at Biocon’s insulin manufacturing facility in Malaysia and issued eight Form 483 observations (view press release); Roche and Alnylam announced a strategic agreement to co-develop and co-commercialize zilebesiran for the treatment of hypertension; and Dario announced a new agreement with an undisclosed large regional health plan as well as preliminary Q2 ’23 results (view press release). Below, FENIX provides highlights and insights for the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

Abbott Q2 ’23 Earnings; Merck Initiates Ph3 Oral PCSK9i Program; Pfizer Partners with Riparian for CV Development; Amarin Corporate Updates; J&J Q2 ’23 Earnings

Five cardiometabolic-related news items have been observed from Abbott, Merck, Pfizer, Amarin, and Johnson & Johnson. Importantly, Abbott disclosed it is converting Libre 2 intermittent scanning CGMs into real-time CGMs through an app update, starting with the UK. Below, FENIX provides highlights and insights from the respective news items, including potential insight into Abbott’s rationale for the Libre 2 LCM initiative.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Novartis Discontinues Ph2 Obesity Asset; Novartis Q2 ‘23 Earnings; Akebia to Resubmit Vadadustat NDA

Two cardiometabolic-related news items have been observed: Novartis hosted its Q2 ‘23 earnings call and disclosed it is discontinuing the development MBL949 in obesity (view press release; slides); and Akebia Therapeutics announced it has completed the End of Dispute Type A meeting with FDA and plans to resubmit the vadadustat NDA for the treatment of anemia due to CKD in adult patients on dialysis in Q3 ‘23 (view press release). Below, FENIX provides highlights and insights into the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Novo and Eleven Therapeutics Collaborate for Nucleic Acid Therapeutics; July CHMP Agenda; Madrigal Completes Resmetirom NDA Submission; Capital Health Partners with Virta Health for Rx Reverse Launch

Four cardiometabolic-related news items have been observed: Eleven Therapeutics announced a collaboration with Novo Nordisk using Eleven’s DELiveri platform to identify molecules for nucleic acid delivery (view press release); the CHMP agenda (view here) for this month’s meeting (July 17-20) has been released; Madrigal announced it completed submission of the resmetirom NDA and requested a priority review (view press release); and Capital Health announced a partnership with Virta Health to launch Rx Reverse, a clinical program designed to help manage cost of treatment for diabetes and obesity (view press release). Below, FENIX provides highlights and insights on the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Lilly to Acquire Versanis Bio; Brenzavvy Available by Prescription at Mark Cuban Cost Plus Drug Company; Abbott Initiates Libre 3 trial in T2DM and Basal Therapy; Nemaura FY ‘22 Earnings Update

Four cardiometabolic-related news items have been observed: Lilly and Versanis Bio announced a definitive agreement for Lilly to acquire Versanis (view press release); TheracosBio announced Brenzavvy (bexagliflozin) is available by prescription through the Mark Cuban Cost Plus Drug Company (view press release); Abbott initiated a new trial evaluating its FreeStyle Libre 3 in adults with T2DM on basal therapy (view CT.gov record); and Nemaura Medical announced business updates and financial results for its FY ‘22 (view press release). Below, FENIX provides highlights and insights into the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Tandem Mobi Receives FDA Clearance; Better Therapeutics’s AspyreRx Receives FDA Authorization for T2DM

Two cardiometabolic-related news items have been observed: Tandem announced FDA clearance of the Tandem Mobi insulin pump for PWD ≥6 years of age (view press release); and Better Therapeutics announced FDA authorized AspyreRx to provide cognitive behavioral therapy for adults with T2DM and held an associated investor call (view press release; webcast). Below, FENIX provides highlights and insights into the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

FENIX Analysis: Thoughts on a Potential Zealand Acquisition

Following ADA 2023, FENIX conducted an analysis regarding a potential impending obesity development/commercialization partnership between two large pharma/biotech companies (view here); however, another compelling question has arisen: with all of the hype around the obesity market, has Zealand Pharma become a more attractive acquisition target? Below, FENIX provides insights and analysis for a potential Zealand acquisition by Boehringer Ingelheim, Novo Nordisk, AstraZeneca, or Amgen, as well as thoughts as to why Amgen could be the most likely suitor.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Novo’s GLP-1RA Drugs Under EMA Review; Novartis’s Entresto Patent Ruled Invalid; FDA Approves Expanded Indication for Leqvio; Tonix Initiates Ph2 Intranasal TNX-1900 Study for Pediatric Obesity

Four cardiometabolic-related news items have been observed: Novo Nordisk’s diabetes and obesity drugs, Ozempic/Wegovy (semaglutide) and Saxenda (liraglutide), are under EMA review following two cases of suicidal ideation and one case of self-harm from users in Iceland (view article); Novartis announced the U.S. District Court for the District of Delaware ruled the patent covering Entresto and combinations of sacubitril and valsartan is invalid (view press release); Novartis also announced FDA approved a label update for Leqvio (inclisiran) to enable earlier use in patients with elevated LDL-C, as an adjunct to diet and statin therapy for patients who have not had a CV event but are at an increased risk for heart disease (view press release); and Tonix Pharmaceuticals announced the first participant has been enrolled in its Ph2 POWER study of TNX-1900, an intranasal potentiated oxytocin, for the treatment of pediatric obesity (view press release; CT.gov record). Below, FENIX provides highlights and insights into the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Lilly Initiates Three New Ph3 Retatrutide Obesity Trials; Zealand Ph1 Amylin Analog Results; Zealand Dasiglucagon CHI NDA Submitted; Sanofi Signs M1Pram Exclusivity Agreement with Adocia; Dexcom G7 Approved in Canada

Five cardiometabolic-related news items have been observed: Lilly initiated three new trials in the Ph3 retatrutide obesity program, TRIUMPH (TRIUMPH-1; TRIUMPH-2; TRIUMPH-4); Zealand announced positive results from Part 1 of the Ph1 MAD trial evaluating its amylin analog, ZP8396 (view press release); Zealand also submitted the dasiglucagon NDA for congenital hyperinsulinism (view press release); Adocia signed an exclusivity agreement with Sanofi for M1Pram (view press release); and Dexcom’s G7 CGM received Health Canada approval for individuals aged 2 years and older (view press release). Below, FENIX provides highlights and insights into the respective news items, including a projected regulatory timeline for retatrutide and brief thoughts on next-gen obesity drugs.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.